DebsResume.docVIP

Devin I. McElroy, M.B.A.Six Sigma Green Belt devin@ Summary of Qualifications Business Qualifications Quality/Regulatory Engineer with almost 15 years experience in Quality Assurance, Quality Control, Regulatory Affairs, and Regulatory Compliance including Field Failure Analysis and Software Quality Assurance Conducted internal audits and mock Quality System audits in compliance with cGMPs, QSRs (QSIT), ISO (CE-mark with Notified Body), and CMDR regulations Analyzed medical device field failures and manufacturing processes and led multiple process improvement projects using standardized methodologies and industry best practices which included PMBOK, SPC, Six Sigma, FMEA, FMECA, and Design For Six Sigma (DFSS) including DOE and pilot programs Prepared numerous regulatory submissions for Class I, II, and III medical devices for national and international distribution in accordance with FDA (CFR), ISO, IEC, MDD, QSR, MEDDEV, JPAL, and TGA requirements Managed multiple Quality System processes including Change Control (ECOs, EWOs, MCOs), Document Control, Supplier/Vendor Qualification program, Regulatory Affairs/Compliance, Inspection Readiness, Quality Auditing Program, Nonconformances (CAPAs, NCMRs), and Quality System standardization across multiple sites Wrote all level of quality and regulatory documentation, including: pharmaceutical recipes following standardized change/document control processes and GLPs; Quality System documentation, Technical/Design Dossiers, and Essential Requirements Checklists Managed department and project personnel within Technical Publications, Quality Assurance, Quality Control, Operational Excellence, Packaging, Labeling, and Distribution (Supply Chain) operations Technical Qualifications Platforms: Windows, UNIX, Linux, and Mac OS Applications: Business: MS Office Pro, Adobe Acrobat Pro, Adobe Technical Communication Suite, FileMaker Pro, FrameMaker, Photoshop, WordPerfect Process/Analytics: Business Objects, Crystal Reports, Brio